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临床试验/NCT07210281
NCT07210281招募中4 期

The Use of Ossein-hydroxyapatite Complex as an Adjunctive Treatment in Orthopedics and Traumatology

University of Opole1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年11月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
period of bone union

研究概览

简要总结

The aim of this study was to evaluate the supportive effect of the ossein-hydroxyapatite complex in fracture healing. The investigators hypothesized that the ossein-hydroxyapatite complex would positively impact fracture healing outcomes.The assessment covers clinical, radiological and biomechanical parameters.

详细描述

The role of ossein-hydroxyapatite complex in fracture healing requires further research.

The aim of the study was to evaluate the effect of ossein-hydroxyapatite complex (Osteogenon) as an adjunctive treatment on the outcome of conservative and surgical fractures treatment via comprehensive clinical, radiological and biomechanical assessments. The investigators aimed to reject the null hypothesis of the absence of beneficial effect of ossein-hydroxyapatite complex on fractures treatment outcomes. This would fill the existing gap in the scientific literature and enable a more widespread use of Osteogenon in the treatment of fractures in many trauma centers.

Patients in the study group with fractures received an ossein-hydroxyapatite complex (830 milligram [mg] of ossein-and-hydroxyapatite complex, with 444 mg of hydroxyapatite, equivalent to 178 mg of calcium and 82 mg of phosphorus) throughout the entire period following fracture healing. The tablets were taken orally, one tablet twice daily.

The drug Osteogenon used in our study had been approved for fracture treatment. The study was conducted in accordance with the Declaration of Helsinki and all applicable laws and regulations. All patients had provided their written informed consent and were informed of a voluntary nature of their participation in this study.

Patients participating in the study, both in the study and control groups, had to meet the inclusion criteria. The randomization method used was to evenly recruit the study and control groups as patients who met the inclusion criteria were recruited. Randomization took into account the equal distribution of gender and age in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no contraindications to taking Osteogenon
  • a follow-up period of more than 3 months after treatment completion
  • complete medical and radiological records
  • a written informed consent
  • not taking any other medications that could affect bone tissue remodeling
  • not taking other medications that interact with Osteogenon
  • no other limb pathologies (inflammatory or neurogenic)
  • absence of comorbidities that could affect bone union

排除标准

  • age under 18 years or over 85 years
  • hypersensitivity to the active ingredient or to any of the excipients
  • severe renal failure and dialysis therapy
  • hypercalcemia
  • hypercalciuria
  • calcium-based kidney stones or tissue calcifications
  • a follow-up period shorter than 3 months after treatment completion
  • a lack of informed consent
  • a lack of cooperation with the patient
  • absent or incomplete medical and radiological records
  • taking medications that could affect bone tissue remodeling
  • taking medications that may interact with Osteogenon (e.g. thiazide diuretics)
  • metabolic disorders
  • post-traumatic skeletal deformities
  • neuromuscular disorders
  • post-inflammatory deformities

研究组 & 干预措施

Osteogenon

Experimental

received an ossein-hydroxyapatite complex

干预措施: received an ossein-hydroxyapatite complex (Drug)

结局指标

主要结局

period of bone union

时间窗: at 6 months after randomisation

assessed by data linkage to medical and radiological records

Achieving bone union

时间窗: at 6 months after randomisation

assessed by data linkage to medical and radiological records

次要结局

  • pain assessment(at 6 months after randomisation)

研究者

发起方
University of Opole
申办方类型
Other
责任方
Principal Investigator
主要研究者

Piotr Morasiewicz

Professor

University of Opole

研究点 (1)

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